Samsung Bioepis said Sunday it presented follow-up results from a Phase 3 study of its Prolia biosimilar, Ovodens (project name SB16), at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) in Prague, Czech Republic.
The analysis was an exploratory subgroup review of the global Phase 3 SB16 trial. It examined 456 postmenopausal women with osteoporosis to assess whether disease characteristics such as age, body mass index and history of vertebral fractures affected the drug’s efficacy.
Samsung Bioepis analyzed the percent change from baseline in bone mineral density of the lumbar spine, total hip and femoral neck at 12 months in patients included in the subgroup analysis for SB16 and the reference product.
The company said the SB16 and reference-product subgroups showed consistent treatment effects, reaffirming biological similarity between the two products.
Shin Dong-hoon, head of the Clinical Medicine Division at Samsung Bioepis, said the company confirmed Ovodens’ consistent treatment effect across diverse patient groups and would strengthen its capabilities to expand evidence-based prescribing of biologic medicines.
* This article has been translated by AI.
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